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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00224523
Other study ID # FFR104503
Secondary ID
Status Completed
Phase Phase 3
First received August 26, 2005
Last updated October 27, 2016
Start date September 2005
Est. completion date February 2007

Study information

Verified date October 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study type Interventional

Clinical Trial Summary

Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.


Description:

A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via Nasal Biopsy in Subjects >18 Years of Age with Perennial Allergic Rhinitis (PAR)


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen.

- Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control.

Exclusion criteria:

- Patients who require certain medications for their allergy.

- Patients with serious medical problems.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
GW685698X

mometasone furoate


Locations

Country Name City State
Belgium GSK Investigational Site Leuven
Netherlands GSK Investigational Site Amsterdam
Netherlands GSK Investigational Site Den Haag
Netherlands GSK Investigational Site Nijmegen

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Netherlands, 

References & Publications (1)

Fokkens W, Hellings P, Blom H, Jansen A, van Drunen K, Clements D, Wu W, Caldwell M, Philpot E. A comparison of the effects of fluticasone furoate and mometasone furoate nasal sprays on the nasal mucosa. Ann Allergy Asthma Immunol 2008; 100(1) (Supplement 1):A12 (abstract)

Outcome

Type Measure Description Time frame Safety issue
Primary Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.
Secondary No Secondary Outcome Measures
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